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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Review of Chemical Analytical Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Memorandum

Date:August 10, 2007
To:Rakesh Pandey Ph.D. OVRR/DVRPA/VVB HFM-478
From:Alfred V. Del Grosso Ph.D. HFM-406 OVRR/DPQ/PQLS
Nora M. Etz , HFM-406 OVRR/DPQ/PQLS
Through:Rajesh Gupta, Ph.D. HFM-407 OVRR/DPQ/PQLS
Subject:CSL Limited Influenza Virus Vaccine (Afluria TM) STN: 125254/0
Review of Chemical Analytical Procedures

Review Summary: We have reviewed the following analytical procedures and associated validation studies submitted in the CMC section of this application.

Analytical Procedures:
QA6657     Taurodeoxycholate by -----
QA5030     Thimerosal by --------------------
QA6211     Thimerosal by ------------------------------------
QA5930     pH
QA6699     ------------------------------------------------------------
QA5567     Protein by -----------------------

The following questions should be asked of the manufacturer and commitments should be made prior to licensure:

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